Frederick National Laboratory for Cancer Research

QA Specialist IV

Job ID: req4316

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

The Vaccine, Immunity and Cancer Directorate (VICD) at the Frederick National Laboratory investigates immune responses to vaccines in preclinical and clinical studies. The Frederick National Laboratory (FNL) and other stakeholders to develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against this new virus. To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to underlying mechanisms of protection against infection, leveraging the vast expertise and excellence in HPV serology at the FNL.

KEY ROLES/RESPONSIBILITIES

The Vaccine, Immunity and Cancer Directorate is seeking an energetic and seasoned Quality Assurance professional with experiences preferably in Serology laboratory with strong knowledge in GCLP to lead and support laboratory quality activities. This is a fully onsite position with no telework option. The QA professional will:

• Lead and perform continuous evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
• Evaluation and monitoring of conformance to established quality assurance processes and standards for testing and laboratory practices
• Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy them
• Develop appropriate risk management strategies
• Assist staff with the creation, implementation, and follow up of Corrective and Preventive Actions
• Recommend alternative courses of action and possible solutions for improvement of workflow, and paperwork management
• Work with laboratory director and manager to plan, qualify, verify, and validate tests/assays and equipment
• Work closely with the laboratory to write SOPs and Quality Assurance plans appropriate for each group
• Participate in the review and revision of standard operating procedures to adhere to regulations
• Working closely with appropriate staff, prepare standard operating procedures for quality control activities
• Review documents for content, accuracy and compliance
• Develop and monitor quality assurance standards
• Prepare guidance documents
• Review records, test results and data for completeness, accuracy, and compliance with specifications and requirements
• Facilitate internal training and quality assurance requirements, processes, and procedures, and maintain training records for staff
• Maintain document control system and ensure version control for all standard operating procedures
• Lead and perform internal audits and risk assessments
• Implement training programs for laboratory personnel on quality assurance requirements, processes, and procedures
• Ensure compliance with SOPs, GCLP/CLIA regulations, and FDA as applicable

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of eight (8) years of leading quality assurance in GCLP or GLP environment.
• Highly experienced in GCLP or GLP, CLIA.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience in quality control and quality assurance related to immunology, virology and/or molecular biology procedures for reagent production and assay development and performance.
• Strong understanding of regulatory and GCLP/CLIA requirements.
• Experience working with standards and reference materials, immune assay (ELISA, multiplex assays) development and validation.
• Excellent communication, organization, and writing skills.

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

90,500.00 - 155,625.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions